Stability of the Effect of a Standardized Meal on QTc
Jörg Täubel1, Sara Fernandes1, Georg Ferber2
1Richmond Pharmacology Ltd., St George's University of London, London, United Kingdom.
Background:
The assessment of QTc changes after the intake of a standardized meal has been proposed as an alternative approach to prove assay sensitivity when the proarrhythimic potential of a drug is to be excluded in either TQT or intensive Phase I QT studies.
Methods:
In this article, an analysis of the food effect at baseline across periods in two different studies is presented to support the robustness of the method.
Results:
The results show that the time-effect attributed to food is stable over different study periods demonstrating consistency of the physiological response triggered by food.
Conclusions:
Stability and reproducibility of the effect is comparable with moxifloxacin.
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